NCT02550275

Brief Summary

Huntington's disease is a rare genetic neurodegenerative disease. It is accompanied by movement disorders, cognitive and behavioral. The social behavior of patients are changed, affecting interpersonal relationships. Patients with Huntington's disease are described as self-centered, lacking sympathy and empathy and mentally inflexible. These behavioral problems can be a major source of anxiety for patients and their families. These disorders also have a negative impact cognitive and motor symptoms as well as the functional abilities and the quality of life of patients and their entourage. Authors have suggested that these problems could be related inter alia to social cognition disorders. This concept refers to a set of skills and emotional and social experiences that regulate relations between individuals and can explain the behavior of individuals and groups. The objective is to evaluate disorders of social cognition, which may account for behavioral changes in Huntington's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 10, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

October 22, 2020

Status Verified

September 1, 2015

Enrollment Period

2.2 years

First QC Date

September 10, 2015

Last Update Submit

October 20, 2020

Conditions

Huntington's Disease

Outcome Measures

Primary Outcomes (1)

  • the achievement of social cognition process in Huntington's disease using the total score of the scale 15-TOM

    3 months after inclusion

Study Arms (3)

presymptomatic patient

OTHER

patient with Unified Huntington's Disease Rating Scale (UHDRS) \< 5

Behavioral: neuropsychological testRadiation: MRI

symptomatic patient

OTHER

patient with Unified Huntington's Disease Rating Scale (UHDRS) \> 5

Behavioral: neuropsychological testRadiation: MRI

controls

OTHER

unaffected patient with Huntington's disease

Behavioral: neuropsychological testRadiation: MRI

Interventions

neuropsychological testBEHAVIORAL
controlspresymptomatic patientsymptomatic patient
MRIRADIATION
controlspresymptomatic patientsymptomatic patient

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For all particpipants
  • Patient gave its written consent
  • between 20 and 70 years
  • School level : at least 7 years
  • native language: french
  • For presymptomatic patient
  • Huntington's disease diagnosed with abnormal number of CAG repeats: 36 \< nucleotide expansion (CAG)
  • Unified Huntington Disease Rating Scale moteur ≤ 5
  • For symptomatic patient
  • Huntington's disease diagnosed with abnormal number of CAG repeats: 36 \< nucleotide expansion (CAG)
  • Unified Huntington Disease Rating Scale moteur \> 5

You may not qualify if:

  • No national health insurance affiliation
  • Being under guardianship
  • Pregnant or lactating women
  • Patient with involuntary movement hampering the realization of MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Angers

Angers, 49000, France

Location

MeSH Terms

Conditions

Huntington Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDementiaChoreaDyskinesiasMovement DisordersHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • SCHERER GAGOU

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2015

First Posted

September 15, 2015

Study Start

January 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

October 22, 2020

Record last verified: 2015-09

Locations

FR(1)